An Implementation Science Approach to Evaluating Self-Administered Acupressure for Knee Osteoarthritis in Older-Aged Adults in the Community

NCT ID: NCT07329023

Last Updated: 2026-01-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 368 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-20
• Study Completion Date: 2028-05-30

Brief Summary

This study aims to evaluate the implementation and effectiveness of a self-administered acupressure (SAA) program for knee osteoarthritis (OA) among older adults in Hong Kong community centers. Using a pragmatic cluster randomized controlled trial (RCT) and mixed-methods approach, the research will assess the reach, adoption, implementation, maintenance, and effectiveness of the SAA program in real-world settings, with the goal of informing scalable interventions for knee OA management.

Detailed Description

Knee OA is a prevalent and debilitating condition in older adults, often managed with medications that have side effects or nonpharmacological interventions requiring significant behavioral change. Acupressure, a variant of acupuncture, can be self-administered after appropriate training and has shown efficacy in previous RCTs for knee OA. This study will implement the SAA program in district elderly community (DEC) centers across Hong Kong, training frontline workers and older adults to deliver and practice acupressure. The intervention includes two training sessions, ongoing support, and a 24-week follow-up. Effectiveness will be measured by pain reduction, improved knee function, and quality of life, while implementation outcomes will be evaluated using the RE-AIM framework. Qualitative interviews will explore facilitators and barriers to adoption and sustainability.

Objectives:

1. To explore the reach, adoption, implementation, and maintenance of the SAA program among community service units.

2. To examine the effectiveness of the SAA program in relieving pain and improving knee function in middle-aged and older adults in real-world settings.

3. To explore the experiences (facilitators and barriers) of adopting SAA in routine services through qualitative interviews.

Hypothesis

• The SAA program will be effectively implemented in community settings, achieving high reach, adoption, fidelity, and sustainability.
• Participants in the SAA group will experience greater reductions in knee pain and improvements in knee function and quality of life compared to the control group.

Design and subjects:

• Design: Pragmatic cluster randomized controlled trial (RCT) with mixed-methods (quantitative and qualitative).
• Setting: District Elderly Community (DEC) centers in Hong Kong.
• Subjects:

• Sample Size: 368 older adults (aged ≥60), recruited from DEC centers (8 clusters per group, 23 participants per cluster).
• Inclusion Criteria: Ethnic Chinese, aged ≥60, able to read Chinese and comprehend Mandarin/Cantonese, probable knee OA (based on clinical criteria), knee pain ≥3 months, pain score ≥3/10, smartphone access, consent.
• Exclusion Criteria: Medical conditions precluding participation, knee pain from other causes, cognitive impairment, BMI >30, prior knee replacement.

Interventions:

• SAA Group (Focus Group):

• Two acupressure training sessions (2 hours each, 1 week apart) led by trained instructors.
• Training includes acupressure technique, knee-health education, practice with feedback, and provision of materials (handouts, rods, logbook).
• Daily home practice (morning and night) for 24 weeks, with ongoing support via WhatsApp and phone calls.
• General Health Education Group (Control Group):

• A general health education booklet will be provided during the study period; will receive the SAA program after 24-week outcome evaluation.

Main outcome measures:

The outcome measures will include treatment effectiveness and implementation.

Effectiveness Outcome Primary outcome measure is the numerical rating scale for knee pain. Other measures include Western Ontario and McMaster University Osteoarthritis Index (WOMAC), Short-Form Six-Dimension (SF-6D), Timed Up & Go Test (TUG) and Fast Gait Speed (FGS).

Implementation Outcome RE-AIM framework will be used to evaluate the project, which covers five aspects of reach, effectiveness, adoption, implementation, and maintenance.

Data Analysis

• Quantitative:

• Double data entry; analysis in SPSS 28.0.
• Baseline differences controlled as covariates.
• Linear mixed-effect models to compare changes in primary (NRS pain score) and secondary outcomes (WOMAC, SF-6D, functional tests) over time.
• Compliance and clinical significance assessed (≥2-point or ≥30% reduction in NRS).
• Intention-to-treat analysis.
• Qualitative:

• Thematic content analysis of interview transcripts using NVivo 12.0.
• Open coding by two independent researchers; themes reviewed for sufficiency and coherence.
• Cost-Effectiveness:

• QALYs calculated from SF-6D.
• Incremental cost-effectiveness ratio (ICER) computed.
• Bootstrapping (5,000 iterations) for uncertainty; cost-effectiveness acceptability curve generated.

Conditions

Knee Osteoarthritis (Knee OA)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Self-Administered Acupressure (SAA) Intervention for Knee Osteoarthritis Management

A training course will be offered to subjects in this group to train them to perform self-acupressure.

Group Type: EXPERIMENTAL

Experimental Group: Self-Administered Acupressure (SAA)

Intervention Type: OTHER

Participants in this group will receive two acupressure training sessions (2 h each, 1 -week apart). The SAA treatment protocol was developed based on TCM meridian theory described in previous studies and modified by the PA and CO-A who is an experienced acupuncturist. The acupoints are indicated for knee pain and are commonly used tested for feasibility in RCT study.

Participants will be asked to perform the acupressure at home in the morning (within 1 h after waking up) and at night (within 1 h after dinner) every day for 24 weeks. Participants will receive a follow-up phone call from the instructor during the first week to remind them to practice and answer their queries.

During the intervention and follow-up period, the participants can communicate with the elderly staff/ our research ambassador to ask questions regarding acupressure.

General Health Education

A booklet of general health education will be offered to the subjects in this group by the research personnel. The research staff will briefly explain the content covered by the booklet and instruct the subjects to read the booklet at home.

Group Type: ACTIVE_COMPARATOR

Control Group: General Health Education

Intervention Type: OTHER

The participants of DEC centers in this group will be provided with the general health education booklets despite the same follow-up procedure. The booklets contains general health education information e.g. physical health, sleep health, for the participants' self-reading. The content is based on our previous studies for lifestyle intervention and health information from the government website. They will be told to read the booklet and follow the suggestions in the booklet. They will have the same program after outcome evaluation at 24 weeks.

Interventions

Experimental Group: Self-Administered Acupressure (SAA)

Participants in this group will receive two acupressure training sessions (2 h each, 1 -week apart). The SAA treatment protocol was developed based on TCM meridian theory described in previous studies and modified by the PA and CO-A who is an experienced acupuncturist. The acupoints are indicated for knee pain and are commonly used tested for feasibility in RCT study.

Participants will be asked to perform the acupressure at home in the morning (within 1 h after waking up) and at night (within 1 h after dinner) every day for 24 weeks. Participants will receive a follow-up phone call from the instructor during the first week to remind them to practice and answer their queries.

During the intervention and follow-up period, the participants can communicate with the elderly staff/ our research ambassador to ask questions regarding acupressure.

Intervention Type: OTHER

Control Group: General Health Education

The participants of DEC centers in this group will be provided with the general health education booklets despite the same follow-up procedure. The booklets contains general health education information e.g. physical health, sleep health, for the participants' self-reading. The content is based on our previous studies for lifestyle intervention and health information from the government website. They will be told to read the booklet and follow the suggestions in the booklet. They will have the same program after outcome evaluation at 24 weeks.

Intervention Type: OTHER

Other Intervention Names

Self-Administered Acupressure(SAA) Intervention for KneeOsteoarthritis Management; General Health Education

Eligibility Criteria

Inclusion Criteria

1. ethnic Chinese;

2. aged 60 years or above;

3. able to read Chinese and comprehend Mandarin or Cantonese;

4. fulfilling any 3 of the following criteria. i. morning stiffness 30 min; ii. crepitus on active joint motion; iii. bone tenderness; iv. bone enlargement; or v. no palpable joint warmth (this classification on those with age >50 years yielded 84% sensitivity, and 89% specificity for OA knee diagnosis (25));

5. having knee pain for at least 3 months (26);

6. knee pain 23 on a Likert pain scale from 1-10;

7. having a smartphone (or a family member living together having a smartphone) that is compatible with WhatsApp (based on our previous studies, almost every eligible subject is used to using WhatsApp for social communication); and

8. willing to provide informed consent.

Exclusion Criteria

1. medical diagnoses or conditions that preclude individuals from active participation (e.g., bleeding disorders, alcohol, or drug abuse);

2. knee pain related to other conditions (cancer, fracture, rheumatoid arthritis, and rheumatism) as screened according to the red flags for further investigation or referral in the NICE 2014 Guidelines for Osteoarthritis of the knee (27);

3. score < 22 in Hong Kong Montreal Cognitive Assessment (HK-MoCA) indicating cognitive impairment that may prevent the understanding of training instructions (28);

4. body mass index over 30, the obese Il criteria for Asians (29) (obese subjects will find great difficulty in performing acupressure on acupoints because physical pressure reaching the muscle is required); and

5. ever had knee-replacement surgery

Further investigation or referral, either at the screening or during the study, will be made whenever necessary.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hong Kong Polytechnic University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

WIng-Fai YEUNG, Phd

Role: PRINCIPAL_INVESTIGATOR

School of Nursing. the Hong Kong Polytechnic University, Hong Kong

Locations

The Hong Kong Polytechnic University

Kowloon, , Hong Kong

Site Status: RECRUITING

Countries

Hong Kong

Central Contacts

Wing-Fai YEUNG, PhD

Role: CONTACT

jerry-wf.yeung@polyu.edu.hk

27664151

Other Identifiers

KOIS

Identifier Type: -

Identifier Source: org_study_id